Systemic Exposure to Atorvastatin Between Asian and Caucasian Subjects: A Combined Analysis of 22 Studies

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Abstract

The aim of the present study was to determine whether there is a differing pattern of systemic exposure to atorvastatin in Asian versus Caucasian subjects by comparison of data obtained from completed pharmacokinetic studies. Pharmacokinetic data were analyzed from completed single-dose (10–80 mg) studies in Asian and Caucasian subjects. Dose normalized area under the concentration-time curve (AUC) and maximum observed concentration (Cmax) (AUCdn and Cmaxdn) were obtained by dividing each value by the administered dose. Dose-per-bodyweight normalized AUC and Cmax (AUCdn,wt and Cmax,dn,wt) were obtained by dividing each value by the administered dose per unit bodyweight. Mean difference and 90% confidence intervals for Asian versus Caucasian comparisons were calculated for atorvastatin pharmacokinetic values based on the t statistic and expressed as ratios using Caucasians as the reference. Data were analyzed from 310 Asians and 579 Caucasians from 22 studies. AUCdn (Asian = 2.35, Caucasian = 2.06 [ng·hr·mL−1]/mg) and Cmaxdn (Asian = 0.39, Caucasian = 0.40 Cmaxdn,wt) and the equivalent dose-per-bodyweight normalized values for atorvastatin (AUCdn,wt: Asian = 157.5, Caucasian = 156.4 [ng·hr·mL−1]/[mg·kg−1]; Cmaxdn,wt: Asian = 26.2, Caucasian = 30.3 [ng·mL−1]/[mg·kg−1]) were similar in both ethnic groups. Mean differences and 90% confidence interval for the differences fell within the limits (0.8–1.25) except for Cmaxdn,wt, for which the lower limit was slightly below 80%. No differences were noted in the systemic exposure to atorvastatin between Asian and Caucasian subjects. These data therefore demonstrate that dosing considerations in the current labels for atorvastatin are similar for Asian compared with Caucasian subjects.

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